PF-Labetalol HCl Injection, USP 20 mg/4 mL (5 mg/mL) vial, Rx Only, Nephron 503B Outsourcing Facility 4500 12th Street Extension West Columbia, SC 29172, NDC 69374-946-34, UPC 3 69374 94634 6.
Reported: November 23, 2022 Initiated: November 10, 2022 #D-0064-2023
Product Description
PF-Labetalol HCl Injection, USP 20 mg/4 mL (5 mg/mL) vial, Rx Only, Nephron 503B Outsourcing Facility 4500 12th Street Extension West Columbia, SC 29172, NDC 69374-946-34, UPC 3 69374 94634 6.
Reason for Recall
CGMP Deviations: Potential for cross contamination due to product carry over.
Details
- Recalling Firm
- Nephron Sterile Compounding Center LLC
- Units Affected
- 34,020 vials
- Distribution
- Nationwide in the USA
- Location
- West Columbia, SC
Frequently Asked Questions
What product was recalled? ▼
PF-Labetalol HCl Injection, USP 20 mg/4 mL (5 mg/mL) vial, Rx Only, Nephron 503B Outsourcing Facility 4500 12th Street Extension West Columbia, SC 29172, NDC 69374-946-34, UPC 3 69374 94634 6.. Recalled by Nephron Sterile Compounding Center LLC. Units affected: 34,020 vials.
Why was this product recalled? ▼
CGMP Deviations: Potential for cross contamination due to product carry over.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 23, 2022. Severity: Moderate. Recall number: D-0064-2023.
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